Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth

NCT04630015 | Completed

• 2 other identifiers: 20805NCI-2020-08530
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.

Conditions

COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Keywords

COVID-19; Cancer Survivorship

Outcome Measures

Primary Outcomes (3)

• Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Anxiety Short Form over time

  The PROMIS Anxiety Short form consists of 2 items addressing patient anxiety with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of anxiety. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.

  Baseline, Week 9, and Week 15, up to 15 weeks total

• Changes in the Patient Reported Outcome Measurement Information System (PROMIS) Depression Short Form over time

  The PROMIS Depression Short form consists of 4 items addressing patient depression with item response scores ranging from 1 (never) to 5 (Always). Raw scores are converted to scaled T-scores with higher scores indicating a greater level of depression. Significant changes over time and trends in patient reported outcomes will be analyzed via student's T-test.

  Baseline, Week 9, and Week 15, up to 15 weeks total

• Changes in the Functional Assessment of Cancer Therapy (FACT-G) scores

  The FACT-G is a 27-item questionnaire designed to measure four domains of health related quality of life (HRQOL) in cancer patients with 4 domains of interest: Physical, social, emotional, and functional well-being. Each tem response score ranges from 0 (not at all) to 5 (very much). The total score is a sum of the subscale scores, with a range from 0 - 108. The higher the score, the better the HRQOL.

  Baseline, Week 9, and Week 15, up to 15 weeks total

Study Arms (1)

Observational (surveys)

Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program.

Other: Survey Administration

Interventions

Survey Administration OTHER

Participants will complete study specific survey

Observational (surveys)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in the Survivorship Wellness Group Program

You may qualify if:

• English-speaking
• Treated for any kind of cancer at UCSF, though finished with active treatments (defined as chemotherapy, radiation, or surgery) at time of enrollment, and without evidence of current active cancer
• Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

You may not qualify if:

• Non-English speaking
• Primary cancer treatment outside of UCSF
• Currently receiving non-maintenance therapies (chemotherapy or radiation) for active cancer
• Psychiatric illness that would affect the ability to participate in a group activity

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

COVID-19; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Margaret Chesney, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 16, 2020
• Study Start: August 31, 2020
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)